Catalog Number

-

Brand Name

Edge

Version/Model Number

Edge

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100590,K100590

Product Code

ONG

Product Code Name

Powered Laser Surgical Instrument With Microbeam\Fractional Output

Public Device Record Key

7f04dc25-182e-468d-b08b-b8ca78aafca0

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

8800020104038

Quantity per Package

1

Contains DI Package

08800020104014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden crate